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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989-04-18 to 1989-04-27
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 1987-02-24
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Silver chloride
EC Number:
232-033-3
EC Name:
Silver chloride
Cas Number:
7783-90-6
Molecular formula:
AgCl
IUPAC Name:
silver(1+) chloride
Details on test material:
- Name of test material (as cited in study report): Silver chloride
- Physical state: white powder
- Storage condition of test material: the test substance was kept at room temperature protected from light
- pH-value: neutral:

Test animals / tissue source

Species:
rabbit
Strain:
other: white russian (albino)
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: 10 months
- Weight at study initiation: 2.23 - 2.66 kg
- Housing: stainless steel cages with grating floor, type ASTA, size: 48.5X40X36.5 cm (LxBxH), ASTA Pharma AG, D-4800 Bielefeld 14; individually housed
- Diet: approx. 120 gram/day x animal, Standard Diet ssniff K, "Special diet for rabbits" supplied by ssniff Spezialfutter GmbH, D-4770 Soest
- Water (ad libitum): srinking quality from the Stadtwerke Bielefeld (Municipal Works)
- Acclimation period: the animals were kept one day under test conditions before application of the product. Veterinary supervision of the animals was done before start of study.

Preliminary inspection of the eye: 24 hours before application of the test substance.

ENVIRONMENTAL CONDITIONS
- Temperature: 20.5 - 23.5 °C
- Relative humidity: 45 - 60 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 gram of the test substance were applied into the conjunctival sac of the left eye. Then both lids were briefly closed by gentle finger pressure. The other eye of each animal was not treated and acted as control.
Duration of treatment / exposure:
not applicable
Observation period (in vivo):
1, 24, 48 and 72 hours p. appl., thereafter once daily 8duration of the observation period: 6 days p. appl.)
Number of animals or in vitro replicates:
3 male rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eye was not rinsed.

SCORING SYSTEM: signs of irritation on the cornea, iris and conjunctiva were assessed quantitatively and qualitatively using the Draize scale. In addition, attention was paid to the occurrence of further reactions on the eye (e.g. corrosive effect) and to clinical symptoms (systemic toxic effects).

TOOL USED TO ASSESS SCORE: the treated eye was examined using a Cliptrix pencil light (supplied by Varta, Hannover, No. 645).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 5 days
Remarks on result:
other: Discharge: amount different from normal at 1 and 24 hour observation.
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Discharge: amount different from normal at 1 hour observation.
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritant / corrosive response data:
The single application of 0.1 gram silver chloride into one conjunctival sac each of three rabbits caused only slight changes on the conjunctiva.
The cornea and the iris were without any findings.
The conjunctiva of all animals reacted with hyperemia (grade 1) during the first observation day. Only in one rabbit the finding lasted up to day 5 of observation.
Slight discharge (grade 1) occurred in two animals on the first day of observation.
The untreated eyes did not show any changes.
Other effects:
There were no systemic toxic effects after conjunctival application of the test substance.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Silver chloride is not irritating to the eyes.
Conclusions:
Silver chloride is not irritating to the eyes.
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified as irritating to the eyes.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as irritating to the eyes.
A pdf document including the calculation of mean irritation scores according to both guidelines is attached to this endpoint study record (please refer to "Attached background material" above).